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Combined Antihypertensive Therapy and Sexual Dysfunction

Information source: LanZhou University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Sexual Dysfunction

Intervention: Felodipine add Irbesartan (Drug); Felodipine add Metoprolol (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: LanZhou University

Official(s) and/or principal investigator(s):
Jing Yu, Professor, Study Chair, Affiliation: The Second Hospital of Lanzhou University

Overall contact:
Jing Yu, Professor, Phone: +86 0931 8942076, Email: yujing2304@126.com


This randomized,active controlled study aimed to compare the effects on sexual function of treatment with combined antihypertensive drugs. The researchers hypothesize that: 1. Both felodipine-irbesartan combination and felodipine-metoprolol combination are effective in lowing blood pressure in patients with essential hypertension. 2. Felodipine-metoprolol combination induces a worse sexual function and a reduction of sex hormone,whereas felodipine-irbesartan combination does not impair sexual function and does not change hormone levels. 3. Oxidative stress decline after both combination regimens. Felodipine-irbesartan combination has a greater impact on oxidative stress indicators than felodipine-metoprolol combination.

Clinical Details

Official title: Effect of Combined Antihypertensive Therapy on Blood Pressure and Sexual Function in Patients With Essential Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Female Sexual Function Index (FSFI)

International Index of Erectile Function(IIEF)

Secondary outcome:

Change of Systolic Blood Pressure in 2 Weeks

Change of Systolic Blood Pressure in 4 Weeks

Change of Systolic Blood Pressure in 8 Weeks

Change of Systolic Blood Pressure in 12 Weeks

Change of Systolic Blood Pressure in 24 Weeks

Change of Systolic Blood Pressure in 48 Weeks

Change of Diastolic Blood Pressure in 2 Weeks

Change of Diastolic Blood Pressure in 4 Weeks

Change of Diastolic Blood Pressure in 8 Weeks

Change of Diastolic Blood Pressure in 12 Weeks

Change of Diastolic Blood Pressure in 24 Weeks

Change of Diastolic Blood Pressure in 48 Weeks

Serum Estradiol in 24 Weeks

Serum Estradiol in 48 Weeks

Serum Testosterone in 24 Weeks

Serum Testosterone in 48 Weeks

Serum MDA in 24 Weeks

Serum MDA in 48 Weeks

Serum 8-OHdG in 24 Weeks

Serum 8-OHdG in 48 Weeks

Serum HNE in 24 Weeks

Serum HNE in 48 Weeks

Detailed description: The effects of hypertension and its pharmacotherapy on sexual function are well known in men,although this topic remains unexplored in women. There is evidence suggests that some classes of antihypertensive drugs such as diuretics and beta-blockers have more negative impact on male sexual function than other classes such as calcium channel blockers(CCBs) and angiotensin-converting enzyme inhibitors(ACEI).Some data suggest that angiotensin Ⅱ antagonists(ARBs) not only do not exacerbate sexual function in males,but even improve it. Treatment with multiple antihypertensive medications was often necessary to attain blood-pressure goals recommended by guidelines. More than two third of patients with 2 or 3 degree of essential hypertension require combination therapy at the beginning of treatment to avoid target organ damage and to minimize the accidence of adverse events. CCBs were recommended by both JNC-7 and ESH / ESC 2007 hypertension guidelines as the basic for the treatment of hypertension. The purpose of this study is to compare the impacts of different CCB-based antihypertensive drugs combination on sexual behavior in both male and female patients with essential hypertension,thus provide evidences for physicians to increase patients adherence to the treatment regimens beside lowing blood pressure.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


Inclusion Criteria:

- Patients with essential hypertension.

- Initial hypertension, or without taking any antihypertensive for at least one month.

- Sexual active.

Exclusion Criteria:

- Patients with secondary hypertension.

- Patients with malignant hypertension, coronary heart disease, diabetes, a history of

syncope, bradycardia (heart rate <45 beats / min), atrioventricular block(Ⅱ or Ⅲ degree), sick sinus syndrome, congestive heart failure, a history of cerebral vascular accidents, serious hepatic and kidney dysfunction, a history of serious mental illness, pregnant, taking oral exogenous estrogens (including contraceptives), hysterectomy, breastfeeding, a history of alcohol or drug abuse, having serious conflict with sexual partner, severity sexual dysfunction.

- Patients refuse to answer questions, refuse to fill in the questionaires,or do not

willing to take blood examination.

Locations and Contacts

Jing Yu, Professor, Phone: +86 0931 8942076, Email: yujing2304@126.com

The Second Hospital of Lanzhou University, Lanzhou, Gansu 730000, China; Recruiting
Ruixin Ma, Doctor, Phone: +86 13893102690, Email: mrxdr@sina.com
Jing Yu, Professor, Phone: +86 13893607559, Email: yujing2304@126.com
Jing Yu, Professor, Principal Investigator
Ruixin Ma, Doctor, Sub-Investigator
Additional Information

Related publications:

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Starting date: April 2008
Last updated: November 10, 2010

Page last updated: August 23, 2015

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